EC Backs Down from May 2022 Deadline in Favor of Progressive IVDR Implementation Rollout

The COVID-19 pandemic has played havoc with the European Union’s (EU) plans to implement an ambitious new device regulation called the In Vitro Diagnostic Regulation (IVDR). On June 7, the European Commission’s (EC) Medical Device Coordination Group (MDCG) unveiled a new joint IVDR implementation and preparedness plan (Plan) targeting a rollout date of May 26, 2022. After resisting industry calls to push the date back, the MDCG has finally relented by announcing a new scheme to rollout the plan progressively. Here’s a briefing on the situation, which is very important for labs that develop new tests and devices for the European market.

How the EC Regulates Diagnostics Devices

The EC and the European Parliament adopted the ((EU) 2017/746) legislative framework for regulation of in vitro medical devices, such as HIV, pregnancy and SARS-CoV-2 tests back in April 2017. The framework is made up of two parts:

• The new medical devices regulation (MDR); and
• The IVDR.

Under the original plan, the MDR was slated to go into effect for two years in May 2020, with the IVDR to replace it in May 2022. Of course, that plan didn’t account for COVID-19. In response to the global pandemic, the MDR was postponed to May 26, 2021; but rather than push back the IVDR, the EC stuck with the May 2022 implementation date and compliance deadline.

Impact on Labs and Device Companies

There’s a lot at stake with these dates. Industry has been complaining about the lack of time to prepare for compliance with the IVDR. Labs, authorized representatives and other stakeholders must carry out major operational tasks such as revising documentation about their products, recruiting new staff and updating internal procedures, to make the transition. Achieving all of this in normal times would have been difficult enough; making the transition during the COVID-19 crisis has made the challenge even greater. created extra challenges.

The IVD industry has been sounding the alarm about preparations for incoming regulation for over a year. One of the biggest concerns is the limited number and capacity of so-called Notified Bodies (NBs) who are responsible for certifying all of the diagnostics that need to be assessed for the first time by May 2022. Under the current EC Directive (98/79/EC), only about 8 percent of all in vitro diagnostics on the market is subject to NB control. The IVDR will bring around 80 percent of in vitro diagnostic medical devices under the control of NBs, the vast majority of them for the first time.

With the deadline less than a year away, only six entities have been able to achieve certification. The EC acknowledged that the lack of certification of NBs so close to the implementation date represents a “grave crisis.”

The New IVDR Rollout Plan

On Oct. 12, the Commission finally announced that it was accepting the inevitable by scrapping the May 2022 IVDR implementation date in favor of a progressive rollout plan. “The unprecedented challenges of the COVID-19 pandemic have diverted resources from Member States, health institutions and economic operators towards addressing the crisis, thereby hampering the capacity to comply on time with the changes introduced,” according to the announcement.

“With more time to prepare for the application of the EU new rules, we will ensure there is a continuous supply of essential in vitro diagnostic medical devices on the market, while not compromising on safety,” noted Stella Kyriakides, Commissioner for Health and Food Safety.

The proposal changes only the IVDR transitional provisions, rather than the substantive rules, with transition periods depending on the type of devices involved. Thus:

• Higher risk devices such as HIV or hepatitis tests (class D) and certain influenza tests (class C), have a transition period until May 2025 and 2026;
• Lower risk devices such as class B and A sterile devices, have a transition period until May 2027.

The Commission also proposes a deferred application of the requirements for so-called “in-house” devices, i.e., those manufactured and used within the same health institution. The new rules include requirements for justification for the use of these devices, as well as rules to ensure their safety and performance.

Takeaway: May 2022 Deadline Still Applies to CE Devices

The new proposal will now go to the European Parliament and Council, where it’s expected to be adopted. Significantly, the plan proposes no change for CE-marked devices that don’t require notified body involvement under the IVDR, nor for devices that are “new”, i.e., devices that have neither a notified body certificate nor a declaration of conformity under the current Directive. Thus, the IVDR for those types of devices, the IVD Regulation will thus still take effect on May 2022, as planned.